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Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer

This study is currently recruiting participants.
Verified April 2013 by Vanderbilt-Ingram Cancer Center
Sponsor:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01222416
First received: September 29, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.


Condition Intervention
Breast Cancer
 Radiation: Radiopharmaceutical Administration [18F]-FDG
Radiation: Radiopharmaceutical: [18F]-FLT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Changes in the standard uptake value (SUV) and Gadolinium contrast parameters will be used as a predictor of response then correlated to complete pathologic response measured at the time of definitive surgery. [ Time Frame: Prior to chemotherapy, within 7-14 days following the start of chemotherapy and immediately prior to surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare and combine magnetic resonance imaging (MRIs) (obtained from study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) methods to develop a robust assessment of tumor status. [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: October 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fluorodeoxyglucose PET/CT (FDG-PET/CT)
A PET/CT scan prior to the initiation of therapy, after the first cycle of therapy, and just prior to initiation of the second cycle of therapy (i.e., up to three scans/patient).
 Radiation: Radiopharmaceutical Administration [18F]-FDG
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
fluorodeoxythymidine PET/CT (FLT-PET/CT)
A PET/CT scan prior to the initiation of therapy, after the first cycle of therapy, and just prior to initiation of the second cycle of therapy (i.e., up to three scans/patient).
 Radiation: Radiopharmaceutical: [18F]-FLT
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with known breast cancer who are receiving neoadjuvant chemotherapy

Criteria

Inclusion Criteria:

  • Subjects must have histologically proven breast cancer
  • Subjects are being considered for preoperative chemotherapy
  • Subjects must be ≥ 18 years old.

Exclusion Criteria:

  • Children will be excluded from this study.
  • Pregnant women and women who are breast feeding will be excluded from this study. (The "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential)
  • Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222416

Contacts
Contact: Clinical Trials Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: A. Bapsi Chak, MD         bapsi.chak@vanderbilt.edu    
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor; Radiation Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01222416     History of Changes
Other Study ID Numbers: VICC BRE 09108
Study First Received: September 29, 2010
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 18, 2013